Olema Oncology has announced another clinical trial collaboration and supply agreement with Novartis for a Phase III trial in metastatic breast cancer, in addition to a $250m private placement to fund ongoing operations and research efforts.
Under the collaboration with Novartis, Olema plans to initiate the pivotal Phase III OPERA-02 clinical trial in mid-2025. The trial will evaluate a combination of Olema’s lead asset palazestrant, with Novartis’s Kisqali (ribociclib) for the frontline treatment of estrogen receptor (ER)+/HER2-negative metastatic breast cancer.
This partnership builds on an initial agreement established in 2020, which has been expanded several times. Last year, the companies increased the size of an earlier Phase I/II study combining palazestrant with CDK4/6 inhibitor Kisqali.
The latest $250m private placement includes participation from both new and existing investors, including Adage Capital Partners LP, Bain Capital Life Sciences, and BVF Partners. The proceeds are set to fund several clinical programmes, including the ongoing OPERA-01 Phase III trial (NCT06016738) for palazestrant monotherapy, with topline data expected in 2026. It will also support the OPERA-02 trial and a Phase I/II study of OP-3136, a KAT6 inhibitor being tested as both a monotherapy and in combination with other treatments.
This funding follows a $130m private placement in 2023 and a $50m credit facility from Silicon Valley Bank, which was used to advance the development of palazestrant.
Palazestrant functions as both a complete estrogen receptor antagonist (CERAN) and selective ER degrader (SERD). It has previously secured fast track designation from the US Food and Drug Administration (FDA) for patients whose cancer has progressed following at least one line of endocrine therapy combined with a CDK4/6 inhibitor.
The treatment landscape for ER+/HER2-negative metastatic breast cancer has advanced in recent years, with a focus on targeted therapies that improve outcomes while managing resistance to endocrine treatments. Combination therapies involving CDK4/6 inhibitors such as Kisqali, Pfizer’s Ibrance (palbociclib), and Eli Lilly’s Verzenio (abemaciclib) have become the standard of care in the frontline setting. These therapies work alongside endocrine treatments such as aromatase inhibitors or SERDs to extend progression-free survival (PFS) by inhibiting cancer cell division.
However, resistance to endocrine therapy remains a key challenge. Agents such as palazestrant are designed to target ER-driven cancers more effectively, including those that have developed resistance. This has led to combinations of CERANs and SERDs with CDK4/6 inhibitors, or other targeted therapies such as PI3K inhibitors and mTOR inhibitors, to further enhance efficacy.
Palazestrant is also being evaluated in Phase I/II combination studies with CDK4/6 inhibitor Ibrance, Novartis’s PI3Ka inhibitor Piqray (alpelisib), and mTOR inhibitor Afinitor (everolimus). According to GlobalData’s Pharma Intelligence Center, palazestrant could generate up to $855m by 2030 if it secured approval.
GlobalData is the parent company of Pharmaceutical Technology.
In March 2023, Olema underwent a corporate restructuring to focus resources on the development of palazestrant. This included a 25% workforce reduction and a strategic shift to prioritise the company’s pipeline around this lead candidate.
